1
Try our simulators
Run free online simulations with your own parameters.
Independent Clinical Data Review
Your second eyes
on the data.
- Independent review, we sit on your side of the table
- Safety, efficacy & exposure-response evaluation
- Free simulators to evaluate your data before engaging
- No long contracts, engage us when you need us
Before The Trial
From lead candidate to IND filing — parallel workstreams, hidden dependencies, and costly rework loops.
Lead Candidate
Target / MOA
Indication
Safety Profile
Modality
Tox Studies
CMC / GMP
PK / ADME
Dose Selection
Meeting Prep
Briefing Package
IND Filing
Parallel
Revise
Rework
Dependency
Characterization
Development
Regulatory Prep
Rework
The Problem
Trial design is slow, and errors cascade across protocols, endpoints, and SAPs.
Study Brief
Indication
Objective
Timeline
Constraints
Population
Eligibility
Analysis
Design
Endpoints
Hypothesis
Sample Size
Protocol
SAP
Review
Revise
Align
Mismatch
Redo
Input
Design Cascade
Deliverables
Review Loops
Rework
How It Works
From simulation to second opinion.
2
Get an independent review
We review your analysis plans, reports, and data packages.
3
Strengthen before submission
Address gaps and build a stronger package with our support.
Output Preview
One brief. Three design paths.
RecommendedPFS primary + ORR secondary, event-driven, strong signal
TradeoffSlower readout than ORR-only, better interpretability
AssumptionsmPFS 4.0 vs 6.3 mo, HR 0.63, 1:1, one futility look
Population2L metastatic NSCLC, post platinum-based progression
StratificationBiomarker status at baseline, pre-randomization capture
EligibilityMeasurable disease, adequate organ function
FlagConfirm screening assumptions, enrollment feasibility check
PrimaryProgression-free survival per RECIST v1.1
EstimandTreatment policy strategy, HR with sensitivity analyses
PopulationITT primary, all randomized by assigned arm
MethodStratified log-rank + Cox, KM curves, sensitivity analyses
FlagConfirm interim boundaries, alpha spending rules to review